There are a number of vascular malformations, defects, or injuries that commonly occur along the lining of the intestine, parts of the gastrointestinal tract or urogenital pathways. Some of the more common types include angiodysplasias or telangiectasias (esophageal, gastric, duodenal, jejunal, ileal, colonic, rectal; Helmrich et al., Southern Medical Journal 83:1450–1453 (1990)), watermelon stomach (Gretz and Achem, Am. J. Gastroentero. 93:890–895 (1998); Binmoeller and Lieberman, Gastrointest Endosc 37:192–193 1991); gastric antral vascular ectasias, and radiation injury (radiation proctitis, esophagitis, gastritis, enteritis). A typical characteristic of these types of disorders is undesired bleeding (Lewis, Gastroenterology Clinics of North America 23:67–91; and Jaspersen et al., Gastrointest Endosc 40:40–44 (1994)). Indeed, gastrointestinal bleeding accounts for at least 2% of all hospital admissions each year (Levy, N. Engl. J. Med 290:1158 (1974)).
Conventional treatment of the foregoing disorders includes thermal treatment (Jensen et al. Gastointest Endosc 45:20–25 (1997); Askin and Lewis, Gastrointest Endosc 43:580–583 (1996), Argon Plasma coagulation (Wahab et al., Endoscopy 29:176–181 (1997), direct pressure (Kirollos, M. J. Urology, 1998 August 160:477–478; Hirokazu, T. J. Urology, 1998 November 160,:1803); and/or laser treatment (Taylor et al., Gastrointest Endosc 52:353:357 (2000)). However, these conventional methods are not without their drawbacks. The medical equipment is relatively costly and can be cumbersome to use. Furthermore, they present the potential risks of perforation (Pierzchajilo, Colonoscopy, 22:451–470 (1995); Bedford et al., Am J Gastroenterol., 87:244–247 (1987)), or in the case of thermal treatment, heart disrhythmias or even colonic explosions (Monahan et al, Gastrointest Endosc 38:40–43 (1992); Vellar et al., Br. J. Surg. 73:157–158 (1986); Donato and Memeo, Dis Colon Rectum 36:291–292 (1993); Shinagawa et al., Br. J. Surg. 72:306 (1985)). Argon plasma coagulation has been shown to cause inflammatory polyps (Schmeck-Lindenau and Heine, Endoscopy 30:93–94 (1998). Further, direct pressure may be insufficient to achieve lasting hemostasis (Hirokazu, T. J. Urology, 1998 November 160:1803).
U.S. Pat. Nos. 6,187,346 and 6,165,492 to Neuwirth et al. disclose chemical cauterization devices and methods used for treatment of lesions occurring in the uterus. The system taught in these patents involves filling the uterus with a caustic agent, such as silver nitrate, and then neutralizing the cauterizing agent with a sodium chloride solution. However, the methods taught in U.S. Pat. Nos. 6,187,346 and 6,165,492 are not applicable to situations where filling a cavity, such as a uterine cavity, is not possible. Furthermore, these patents do not teach devices that control delivery of a caustic agent as to allow for controlled treatment of a limited area of tissue.
In view of the problems associated with traditional treatments, there is a need in the art for a cautery method that overcomes these problems, and provides an easy to use, inexpensive system for cauterization. While gastroenterologists encounter a number of chronic bleeding disorders, other medical disciplines, such as otorhinolaryngology, pulmonology, gynecology, urology, general surgery, thoracic surgery, and orthopedic surgery, may encounter deformations, defects, and/or injuries that result in undesired bleeding as well. Ideally, the new cautery method would be readily adaptable for use in medical procedures in the GI tract but also other organ systems. For example, transurethral resection of the prostate, or retropubic prostatectomy may lead to massive bleeding and an inability to achieve hemostasis in some patients (Touyama H. J. Urology, 1998 November 160:1803; Kirollos. M. J. Urology 1998 August 160:477–478). Studies related to these types of surgeries have discussed the problems of severe intra-operative bleeding. In most instances arterial bleeding can be controlled through electrocoagulation, whereas venous bleeding can be controlled by placing the catheter on traction and over-inflating the catheter balloon to create pressure sufficient to stop bleeding and promote coagulation. However, not all bleeding is of arterial origin and catheter traction to reduce post-operative venous bleeding only works when applied, having no effect after removal. (Walker E M. et al Br. J. Urol 1995 May: 75(5):614–7) In those patients with severe arteriovenous malformation, these procedures are insufficient to achieve complete hemostasis, leading to continued blood loss which may become life threatening. (Touyama, H. J. Urology 1998 November 160:1803). The double lumen catheter of the present invention solves this problem.